Bavituximab: Updated Phase IIb data

Peregrine said investors should not rely on data previously reported from a double-blind, placebo-controlled, international Phase IIb trial evaluating bavituximab plus docetaxel for the second-line treatment of NSCLC. Peregrine said it discovered "major discrepancies between some patient sample test results and patient treatment code assignments" while preparing for an end-of-Phase II meeting with FDA. The company added that the source of these discrepancies "appear to have been associated with the independent third party contracted to code and distribute investigational drug product." Peregrine declined to disclose additional details, but said it will communicate further after conducting a review. The trial enrolled 121 patients to receive 1 or 3 mg/kg bavituximab plus docetaxel or docetaxel plus placebo.

In May, Peregrine reported top-line data from the trial for the primary endpoint of ORR and secondary endpoint of median PFS (see BioCentury, May 28). Last month, the company said bavituximab plus docetaxel significantly improved median OS compared to docetaxel alone in the trial (see BioCentury, Sept 10). ...